Industry News and Headlines

Competitive Generic Therapy Approvals

The FDA’s Office of Generic Drugs has launched a public, bi‑weekly list of all approved abbreviated new drug applications (ANDAs) that carry a Competitive Generic Therapy (CGT) designation. The list details each product’s reference listed drug, NDA number, applicant, active ingredient, approval date, and whether it qualifies for the 180‑day CGT exclusivity, including forfeiture status and first commercial marketing date. By publishing this data, the agency aims to increase transparency for prospective generic applicants and illustrate how CGT provisions are being used to stimulate competition where it is lacking. The list also mirrors CGT coding in the Orange Book, showing exclusivity expiration dates.